Global Regulatory CMC Director - Small Molecule (Remote)

Regulatory Jobs; Indianapolis (IN); Hybrid; USD 149,000 - 257,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a regulatory CMC leader to drive strategic, tactical, and operational CMC activities across modalities and technologies to accelerate the small molecule portfolio. You will guide development teams, craft regulatory strategies, and provide timely regulatory advice to support global submissions and lifecycle planning.

The role emphasizes deep technical CMC expertise, leadership, and collaboration with project teams to align across

Qualifications

• B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules.

Responsibilities

• Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
• Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment.

Skills

Regulatory CMC experience

Leadership

Regulatory strategy

Communication

Education

B.S. in science/engineering

Advanced degree preferred

Job description

Lilly, headquartered in Indianapolis, Indiana, is seeking a regulatory CMC leader to drive strategic, tactical, and operational CMC activities across modalities and technologies to accelerate the small molecule portfolio. You will guide development teams, craft regulatory strategies, and provide timely regulatory advice to support global submissions and lifecycle planning.

The role emphasizes deep technical CMC expertise, leadership, and collaboration with project teams to align across